The Vaping Post: Michael Siegel from Boston University roughly estimates to $300,000 the cost for the manufacturer to file a single PTMA (Pre-Market Tobacco Application), a procedure that the FDA recognizes as a 1,500-hour labour.
A back-of-the-envelop calculation gives a $20-million capital cost for a manufacturer aiming at authorizing 20 flavors in 3 nicotine strengths. Based on these figures, a huge decrease in the variety of e-liquids is expected in stores, mainly favoring the larges companies and sweeping out the smallest ones.
As a well established vendor in New York, how do you welcome such regulation from the FDA?
Peter Denholtz: I believe that our industry needs to be regulated. I believe that those regulations should be concerned with manufacturing standards and packaging – ensuring product is produced safely and ensuring that consumers understand what they are purchasing.
I believe that the FDA has severely over-reached and the regulations are not based upon the facts. I believe that other powers are driving the regulations – more specifically, the tobacco and pharmaceutical industries.
I believe that if the discussions which led to the FDA regulations were started today, the regulations would be different. Many facts have emerged in favor of vaping that have not been considered in this process.
I believe that the FDA regulations will result in most vape companies going out of business. They either won’t have the product to sell or they won’t have the ability to fund the PMTA process.
I believe that the FDA regulations have killed the innovation in this industry, just at a time when we are finding better and safer means of vaping.
I believe that the FDA regulations will result in a booming black market. In other words, the industry will continue to evolve behind closed doors and the public will see very little of these innovations.
I believe that the FDA regulations will result in more health issues and problems from vaping. From trying to make one’s own ejuice to building one’s own mod – disasters lurk around every corner and the FDA will be the cause of these issues due to the fact that they are not providing a clear path for new and better products to emerge.
In other words, apply standards and restrictions that make sense rather than forcing manufacturers of vaping products to use an old cigarette model that does not apply.
My hope is that eventually (sooner rather than later) the FDA will take the stance that the UK has taken in regard to vaping. It seems the UK, knowing that traditional cigarettes kill you, is trying to embrace vaping as a viable alternative to smoking. In doing so, they are doing all that they can to educate the pubic on the benefits of vaping in hopes of moving people off of cigarettes.
The UK recognizes the potential positive health ramifications of switching people from smoking to vaping and is encouraging the public to do so. Unfortunately, the US is doing all that they can to prevent people from vaping. Case in point… the head of the Center for Disease control made an announcement a few months ago. He stated “Vaping has risen at an alarming rate among teens”. What he failed to include was the rest of the sentence… “and smoking is at an all time low among teens”.
There is a direct correlation yet the CDC is more concerned with not getting another generation hooked on nicotine rather than getting kids to move from a product that we know has a strong possibility of killing them.
How do you think this will impact your business?
Peter: Henley is a retailer and retailers are going to be hurt badly. The lack of new products will force retailers to sell the same products. This means that retailers will begin to compete on price. Margins will dry up and retailers will have a hard time paying their rent and other bills. Fortunately, Henley has worked hard to differentiate our stores by creating a space for community – whether it is the vaping community, the arts, or promoting philanthropic causes. We believe that differentiating and carrying synergist products will be the best chance of succeeding.
What are your customers saying about the new regs? Do they realize what will happen? Are they are concerned by the situation?
Peter: The “enthusiasts” know the story. Others hear bits and pieces and are not too sure what’s going on. The enthusiasts seem concerned, but at the same time they are the ones that have driven this industry to where it is thus far. I don’t think they are so concerned because they will continue to innovate behind closed doors.
What message would you like to convey to the other industry professionals?
Peter: There is no stopping this train. I strongly believe that regardless of the regulations that vaping is here to stay. The question is how does one remain in the game throughout this difficult time. Outside of dealing with the business issues, each of us has to do our best to educate the public and get involved when there is an opportunity to do so with legislators and regulators. If our belief that vaping is a healthier alternative to smoking is true, than eventually the truth will prevail. Find a way to hang in there!
And to the vapers in general?
Peter: I have so much respect for the vaping community, but what makes them great is also what makes them frowned upon by many. They are an irreverent bunch and I think they view vaping as a legitimate means to make a statement. The best thing vaping enthusiasts can do right now is to dial back the rebelliousness and vape respectfully and responsibly. They are a powerful community if they can get all of their ships sailing in the same direction.
Any last words ?
Peter: Electronic cigarettes may be the greatest life saving products invented in our life time. We all knows the statistics. I am so proud to have had the opportunity to further the acceptance and use of these products with a great team of people who share my beliefs. In the end, I believe that we will all find ourselves on the right side of history.
We’d like to thank Peter for answering our questions. If you live in NYC and want to enjoy a friendly vaping experience, Peter’s shop address is : 23 Cleveland Place, NY, NY 10023 or visit henleyvape.com for more information. Peter among many others will be seen in the documentary Beyond the cloud that will be soon released for free on social medias.